Efficacy and Safety of Pembrolizumab (MK-3475) With Plati... | NCT03425643

ID	Type	Description
MK-3475-671	Other Identifier	MSD
183970	Other Identifier	JAPIC-CTI
2017-001832-21	EudraCT Number

Label	Type	Description	Intervention Names
NAC + Neoadjuvant/Adjuvant Pembrolizumab	Experimental	Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, intravenous (IV); given on cycle day 1] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin [75 mg/m^2, IV; given on cycle day 1] and either Gemcitabine [1000 mg/m^2, IV; given on cycle days 1 and 8] or Pemetrexed [500 mg/m^2, IV; given on cycle day 1]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, IV; given on cycle day 1].	Biological: Pembrolizumab Drug: Cisplatin Drug: Gemcitabine Drug: Pemetrexed
NAC + Neoadjuvant/Adjuvant Placebo	Placebo Comparator	Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo [normal saline, IV; given on cycle day 1] in combination with platinum doublet NAC, consisting of cisplatin [75 mg/m^2, IV; given on cycle day 1] and either Gemcitabine [1000 mg/m^2, IV; given on cycle days 1 and 8] or Pemetrexed [500 mg/m^2, IV; given on cycle day 1]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo [normal saline, IV; given on cycle day 1].	Drug: Placebo Drug: Cisplatin Drug: Gemcitabine Drug: Pemetrexed

Name	Type	Description	Arm Group Labels	Other Names
Pembrolizumab	Biological	200 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1.	NAC + Neoadjuvant/Adjuvant Pembrolizumab

Measure	Description	Time Frame
Event Free Survival (EFS)	EFS is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause. EFS determined either by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). The EFS for all participants is presented (through database cut-off date of 10-Jul-2023).	Up to approximately 5 years
Overall Survival (OS)	OS is defined as the time from randomization until death from any cause. The OS for all participants is presented (through database cut-off date of 10-Jul-2023).	Up to approximately 5 years

Measure	Description	Time Frame
Major Pathological Response (mPR) Rate	mPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy. The mPR rates as assessed by blinded independent pathologist are presented.	Up to approximately 8 weeks following completion of neoadjuvant treatment (up to Study Week 20)

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Banner MD Anderson Cancer Center ( Site 0028)		Gilbert	Arizona	85234	United States
Western Regional Medical Center, Inc. ( Site 0050)

PubMed Identifier	Type	Citation	Retractions
39288781	Result	Spicer JD, Garassino MC, Wakelee H, Liberman M, Kato T, Tsuboi M, Lee SH, Chen KN, Dooms C, Majem M, Eigendorff E, Martinengo GL, Bylicki O, Rodriguez-Abreu D, Chaft JE, Novello S, Yang J, Arunachalam A, Keller SM, Samkari A, Gao S; KEYNOTE-671 Investigators. Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024 Sep 28;404(10459):1240-1252. doi: 10.1016/S0140-6736(24)01756-2. Epub 2024 Sep 14.
37272513

Label	URL
Merck Clinical Trials Information	View source

ID	Title	Description
FG000	NAC + Neoadjuvant/Adjuvant Pembrolizumab	Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, intravenous (IV); given on cycle day 1] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin [75 mg/m^2, IV; given on cycle day 1] and either Gemcitabine [1000 mg/m^2, IV; given on cycle days 1 and 8] or Pemetrexed [500 mg/m^2, IV; given on cycle day 1]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, IV; given on cycle day 1].

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Nov 29, 2022

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Event Free Survival (EFS)

EFS is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause. EFS determined either by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). The EFS for all participants is presented (through database cut-off date of 10-Jul-2023).

The analysis population consisted of all randomized participants.

Posted

Median

95% Confidence Interval

Months

Up to approximately 5 years

ID	Title	Description
OG000	NAC + Neoadjuvant/Adjuvant Pembrolizumab	Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, intravenous (IV); given on cycle day 1] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin [75 mg/m^2, IV; given on cycle day 1] and either Gemcitabine [1000 mg/m^2, IV; given on cycle days 1 and 8] or Pemetrexed [500 mg/m^2, IV; given on cycle day 1]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, IV; given on cycle day 1].
OG001	NAC + Neoadjuvant/Adjuvant Placebo	Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo [normal saline, IV; given on cycle day 1] in combination with platinum doublet NAC, consisting of cisplatin [75 mg/m^2, IV; given on cycle day 1] and either Gemcitabine [1000 mg/m^2, IV; given on cycle days 1 and 8] or Pemetrexed [500 mg/m^2, IV; given on cycle day 1]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo [normal saline, IV; given on cycle day 1].

Units	Counts
Participants	OG000397 OG001400

Title

Denominators

Categories

Title	Measurements
	OG00047.2(32.9 to NA)NA = Upper limit not reached at time of data cut-off OG00118.3(14.8 to 22.1)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		<0.00001	One-sided p-value based on log-rank test stratified by Stage (II versus III), TPS (>=50% versus <50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).	Hazard Ratio (HR)	0.59			2-Sided	95	0.48	0.72			Stratified Cox model with Efron's tie handling method with treatment as a covariate stratified by Stage (II versus III), TPS (>=50% versus <50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).		Superiority

Primary

Overall Survival (OS)

OS is defined as the time from randomization until death from any cause. The OS for all participants is presented (through database cut-off date of 10-Jul-2023).

The analysis population consisted of all randomized participants.

Posted

Median

95% Confidence Interval

Months

Up to approximately 5 years

ID	Title	Description
OG000	NAC + Neoadjuvant/Adjuvant Pembrolizumab	Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, intravenous (IV); given on cycle day 1] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin [75 mg/m^2, IV; given on cycle day 1] and either Gemcitabine [1000 mg/m^2, IV; given on cycle days 1 and 8] or Pemetrexed [500 mg/m^2, IV; given on cycle day 1]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, IV; given on cycle day 1].
OG001	NAC + Neoadjuvant/Adjuvant Placebo	Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo [normal saline, IV; given on cycle day 1] in combination with platinum doublet NAC, consisting of cisplatin [75 mg/m^2, IV; given on cycle day 1] and either Gemcitabine [1000 mg/m^2, IV; given on cycle days 1 and 8] or Pemetrexed [500 mg/m^2, IV; given on cycle day 1]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo [normal saline, IV; given on cycle day 1].

Secondary

Major Pathological Response (mPR) Rate

mPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy. The mPR rates as assessed by blinded independent pathologist are presented.

The analysis population consisted of all randomized participants.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 8 weeks following completion of neoadjuvant treatment (up to Study Week 20)

ID	Title	Description
OG000	NAC + Neoadjuvant/Adjuvant Pembrolizumab	Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, intravenous (IV); given on cycle day 1] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin [75 mg/m^2, IV; given on cycle day 1] and either Gemcitabine [1000 mg/m^2, IV; given on cycle days 1 and 8] or Pemetrexed [500 mg/m^2, IV; given on cycle day 1]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, IV; given on cycle day 1].
OG001	NAC + Neoadjuvant/Adjuvant Placebo	Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo [normal saline, IV; given on cycle day 1] in combination with platinum doublet NAC, consisting of cisplatin [75 mg/m^2, IV; given on cycle day 1] and either Gemcitabine [1000 mg/m^2, IV; given on cycle days 1 and 8] or Pemetrexed [500 mg/m^2, IV; given on cycle day 1]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo [normal saline, IV; given on cycle day 1].

Secondary

Pathological Complete Response (pCR) Rate

pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy. The pCR rates as assessed by blinded independent pathologist are presented.

The analysis population consisted of all randomized participants.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 8 weeks following completion of neoadjuvant treatment (up to Study Week 20)

ID	Title	Description
OG000	NAC + Neoadjuvant/Adjuvant Pembrolizumab	Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, intravenous (IV); given on cycle day 1] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin [75 mg/m^2, IV; given on cycle day 1] and either Gemcitabine [1000 mg/m^2, IV; given on cycle days 1 and 8] or Pemetrexed [500 mg/m^2, IV; given on cycle day 1]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, IV; given on cycle day 1].
OG001	NAC + Neoadjuvant/Adjuvant Placebo	Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo [normal saline, IV; given on cycle day 1] in combination with platinum doublet NAC, consisting of cisplatin [75 mg/m^2, IV; given on cycle day 1] and either Gemcitabine [1000 mg/m^2, IV; given on cycle days 1 and 8] or Pemetrexed [500 mg/m^2, IV; given on cycle day 1]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo [normal saline, IV; given on cycle day 1].

Secondary

Change From Baseline in Neoadjuvant Phase in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) Score

Change from baseline in GHS/QoL score using the EORTC QLQ-C30 will be determined. The EORTC QLQ-C30 is the most widely used cancer-specific, health-related QoL instrument comprised of 30 individual items arranged as both multi-item scales and individual items. Specifically, these items are divided into 5 functional scales (15 items total), 3 symptom scales (7 items total), 6 individual items, and a GHS/QoL scale composed of 2 items: GHS and QoL. The GHS/QoL score measured here refers to only the composite score calculated for the GHS/QoL scale. Both items on the GHS/QoL scale are scored from 1 (very poor GHS/QoL) to 7 (excellent GHS/QoL) and scores for both items are averaged and a linear transformation applied to standardize the overall GHS/QoL score from 0 to 100, with higher overall scores indicating higher GHS/QoL.

All randomized participants who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Item 30 assessment data available.

Posted

Least Squares Mean

95% Confidence Interval

Sore on a scale

Baseline (cycle 1 in neoadjuvant phase) and neoadjuvant week 11

ID	Title	Description
OG000	NAC + Neoadjuvant/Adjuvant Pembrolizumab	Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, intravenous (IV); given on cycle day 1] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin [75 mg/m^2, IV; given on cycle day 1] and either Gemcitabine [1000 mg/m^2, IV; given on cycle days 1 and 8] or Pemetrexed [500 mg/m^2, IV; given on cycle day 1]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, IV; given on cycle day 1].

Secondary

Change From Baseline in Adjuvant Phase in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) Score

All randomized participants who received at least one dose of study treatment and have at least one EORTC-QLQ-C30 Item 30 assessment data available.

Posted

Least Squares Mean

95% Confidence Interval

Sore on a scale

Baseline (cycle 1 in neoadjuvant phase) and adjuvant week 10 (up to Study Week 30)

ID	Title	Description
OG000	NAC + Neoadjuvant/Adjuvant Pembrolizumab	Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, intravenous (IV); given on cycle day 1] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin [75 mg/m^2, IV; given on cycle day 1] and either Gemcitabine [1000 mg/m^2, IV; given on cycle days 1 and 8] or Pemetrexed [500 mg/m^2, IV; given on cycle day 1]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, IV; given on cycle day 1].

Secondary

Number of Participants Who Experience an Adverse Event (AE)

Not Posted

Jun 2027

Up to approximately 71 weeks

Participants

Secondary

Number of Participants Who Experience Perioperative Complications

Perioperative complications are a discrete set of both intraoperative and postoperative complications, potentially contributing to increased length of inpatient care and/or delay of adjuvant therapy. The number of participants experiencing perioperative complications will be assessed.

The analysis population consisted of all randomized participants who received at least one dose of neoadjuvant study treatment and also undergo on-study surgery.

Posted

Count of Participants

Participants

Up to approximately 51 weeks following surgery

ID	Title	Description
OG000	NAC + Neoadjuvant/Adjuvant Pembrolizumab	Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, intravenous (IV); given on cycle day 1] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin [75 mg/m^2, IV; given on cycle day 1] and either Gemcitabine [1000 mg/m^2, IV; given on cycle days 1 and 8] or Pemetrexed [500 mg/m^2, IV; given on cycle day 1]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, IV; given on cycle day 1].
OG001	NAC + Neoadjuvant/Adjuvant Placebo	Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo [normal saline, IV; given on cycle day 1] in combination with platinum doublet NAC, consisting of cisplatin [75 mg/m^2, IV; given on cycle day 1] and either Gemcitabine [1000 mg/m^2, IV; given on cycle days 1 and 8] or Pemetrexed [500 mg/m^2, IV; given on cycle day 1]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo [normal saline, IV; given on cycle day 1].

Secondary

Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)

Not Posted

Jun 2027

Up to approximately 57 weeks

Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0008 events8 affected396 at risk EG0014 events3 affected399 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected396 at risk EG0010 events0 affected399 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0011 events1 affected399 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected396 at risk EG0013 events3 affected399 at risk
Angina pectoris	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0012 events2 affected399 at risk
Arrhythmia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0012 events2 affected399 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected396 at risk EG0013 events3 affected399 at risk
Atrial flutter	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Atrial thrombosis	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Cardiac arrest	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Cardiac failure	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected396 at risk EG0011 events1 affected399 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Myocardial infarction	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Myocarditis	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Pericardial effusion	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Pericarditis	Cardiac disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Hypophysitis	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Hypopituitarism	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Hypothyroidism	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected396 at risk EG0010 events0 affected399 at risk
Colitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected396 at risk EG0010 events0 affected399 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0007 events5 affected396 at risk EG0013 events3 affected399 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Melaena	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Mesenteric artery stenosis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected396 at risk EG0015 events5 affected399 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected396 at risk EG0010 events0 affected399 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected396 at risk EG0011 events1 affected399 at risk
Chest pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Condition aggravated	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Death	General disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected396 at risk EG0011 events1 affected399 at risk
Fatigue	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0012 events1 affected399 at risk
General physical health deterioration	General disorders	MedDRA 26.0	Systematic Assessment	EG0004 events3 affected396 at risk EG0011 events1 affected399 at risk
Localised oedema	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Malaise	General disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected396 at risk EG0012 events2 affected399 at risk
Non-cardiac chest pain	General disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0013 events3 affected399 at risk
Pyrexia	General disorders	MedDRA 26.0	Systematic Assessment	EG0008 events8 affected396 at risk EG0011 events1 affected399 at risk
Sudden cardiac death	General disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Hepatic mass	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0011 events1 affected399 at risk
Bacteraemia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0011 events1 affected399 at risk
Bronchitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected396 at risk EG0011 events1 affected399 at risk
COVID-19	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected396 at risk EG0011 events1 affected399 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected396 at risk EG0010 events0 affected399 at risk
Cholecystitis infective	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Cystitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Diverticulitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Empyema	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Gastroenteritis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected396 at risk EG0011 events1 affected399 at risk
Hepatitis E	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Impetigo	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected396 at risk EG0011 events1 affected399 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0011 events1 affected399 at risk
Lung abscess	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Pleural infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00025 events21 affected396 at risk EG00121 events19 affected399 at risk
Pneumonia aspiration	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Postoperative wound infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Pyelonephritis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected396 at risk EG0011 events1 affected399 at risk
Septic shock	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0011 events1 affected399 at risk
Soft tissue infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Systemic infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Tracheobronchitis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected396 at risk EG0011 events1 affected399 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0011 events1 affected399 at risk
Urosepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0011 events1 affected399 at risk
Viral infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Anastomotic fistula	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Arterial injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected396 at risk EG0010 events0 affected399 at risk
Epidural haemorrhage	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected396 at risk EG0010 events0 affected399 at risk
Incision site haemorrhage	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Post procedural discharge	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Post procedural fistula	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Postoperative thoracic procedure complication	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected396 at risk EG0011 events1 affected399 at risk
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Alanine aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected396 at risk EG0011 events1 affected399 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0007 events7 affected396 at risk EG0011 events1 affected399 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Blood creatinine increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0011 events1 affected399 at risk
Lipase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Neutrophil count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0006 events6 affected396 at risk EG0011 events1 affected399 at risk
Platelet count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected396 at risk EG00110 events10 affected399 at risk
White blood cell count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0004 events3 affected396 at risk EG0011 events1 affected399 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0011 events1 affected399 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected396 at risk EG0010 events0 affected399 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected396 at risk EG0010 events0 affected399 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Chest wall haematoma	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Benign anorectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Cerebral infarction	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0005 events5 affected396 at risk EG0010 events0 affected399 at risk
Cognitive disorder	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Embolic cerebral infarction	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Lethargy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Multiple sclerosis	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Myasthenic syndrome	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Myelopathy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Peripheral sensorimotor neuropathy	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Syncope	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0013 events3 affected399 at risk
Tremor	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Confusional state	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected396 at risk EG0010 events0 affected399 at risk
Delirium	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Depression	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Suicide attempt	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected396 at risk EG0014 events4 affected399 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Renal colic	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Renal failure	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0003 events3 affected396 at risk EG0013 events3 affected399 at risk
Renal impairment	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0013 events3 affected399 at risk
Renal injury	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected396 at risk EG0011 events1 affected399 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected396 at risk EG0010 events0 affected399 at risk
Bronchial fistula	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0011 events1 affected399 at risk
Bronchopleural fistula	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected396 at risk EG0013 events3 affected399 at risk
Bronchostenosis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected396 at risk EG0010 events0 affected399 at risk
Chylothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected396 at risk EG0013 events2 affected399 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0004 events4 affected396 at risk EG0011 events1 affected399 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0011 events1 affected399 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0004 events3 affected396 at risk EG0017 events7 affected399 at risk
Pleural fistula	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0006 events5 affected396 at risk EG0011 events1 affected399 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0006 events6 affected396 at risk EG0014 events4 affected399 at risk
Pulmonary air leakage	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0014 events4 affected399 at risk
Pulmonary artery thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0009 events9 affected396 at risk EG0019 events9 affected399 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0011 events1 affected399 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected396 at risk EG0010 events0 affected399 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected396 at risk EG0012 events2 affected399 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0012 events2 affected399 at risk
Arterial haemorrhage	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0000 events0 affected396 at risk EG0011 events1 affected399 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0002 events1 affected396 at risk EG0011 events1 affected399 at risk
Embolism	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0011 events1 affected399 at risk
Hypertension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0011 events1 affected399 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0011 events1 affected399 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected396 at risk EG0011 events1 affected399 at risk
Thrombosis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk
Vena cava thrombosis	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG0001 events1 affected396 at risk EG0010 events0 affected399 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment	EG000229 events163 affected396 at risk EG001233 events165 affected399 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 26.0	Systematic Assessment	EG00031 events29 affected396 at risk EG00125 events23 affected399 at risk
Hypothyroidism	Endocrine disorders	MedDRA 26.0	Systematic Assessment	EG00046 events42 affected396 at risk EG0016 events6 affected399 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00022 events22 affected396 at risk EG00119 events18 affected399 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG000207 events154 affected396 at risk EG001205 events146 affected399 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG000113 events78 affected396 at risk EG001101 events73 affected399 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00028 events24 affected396 at risk EG00126 events22 affected399 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG000385 events228 affected396 at risk EG001347 events210 affected399 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG00052 events41 affected396 at risk EG00142 events36 affected399 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG000119 events81 affected396 at risk EG001103 events68 affected399 at risk
Asthenia	General disorders	MedDRA 26.0	Systematic Assessment	EG00073 events58 affected396 at risk EG00195 events65 affected399 at risk
Chest pain	General disorders	MedDRA 26.0	Systematic Assessment	EG00048 events46 affected396 at risk EG00137 events33 affected399 at risk
Fatigue	General disorders	MedDRA 26.0	Systematic Assessment	EG000174 events125 affected396 at risk EG001139 events101 affected399 at risk
Malaise	General disorders	MedDRA 26.0	Systematic Assessment	EG00046 events36 affected396 at risk EG00149 events28 affected399 at risk
Oedema peripheral	General disorders	MedDRA 26.0	Systematic Assessment	EG00047 events40 affected396 at risk EG00129 events24 affected399 at risk
Pyrexia	General disorders	MedDRA 26.0	Systematic Assessment	EG00055 events43 affected396 at risk EG00133 events31 affected399 at risk
Pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00017 events15 affected396 at risk EG00122 events20 affected399 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00022 events21 affected396 at risk EG00118 events12 affected399 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.0	Systematic Assessment	EG00025 events20 affected396 at risk EG00123 events16 affected399 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG00023 events23 affected396 at risk EG00118 events18 affected399 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment	EG00062 events61 affected396 at risk EG00159 events59 affected399 at risk
Alanine aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00081 events57 affected396 at risk EG00164 events40 affected399 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00063 events42 affected396 at risk EG00145 events32 affected399 at risk
Blood creatinine increased	Investigations	MedDRA 26.0	Systematic Assessment	EG000101 events69 affected396 at risk EG00188 events59 affected399 at risk
Blood urea increased	Investigations	MedDRA 26.0	Systematic Assessment	EG00032 events21 affected396 at risk EG00122 events16 affected399 at risk
Lymphocyte count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG00046 events24 affected396 at risk EG00156 events26 affected399 at risk
Neutrophil count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG000296 events171 affected396 at risk EG001303 events169 affected399 at risk
Platelet count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG000115 events74 affected396 at risk EG001106 events73 affected399 at risk
Weight decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG00035 events32 affected396 at risk EG00126 events24 affected399 at risk
White blood cell count decreased	Investigations	MedDRA 26.0	Systematic Assessment	EG000202 events112 affected396 at risk EG001202 events102 affected399 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG000166 events115 affected396 at risk EG001147 events102 affected399 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00049 events26 affected396 at risk EG00168 events42 affected399 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00048 events32 affected396 at risk EG00131 events20 affected399 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00032 events19 affected396 at risk EG00141 events23 affected399 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00048 events30 affected396 at risk EG00151 events40 affected399 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00070 events49 affected396 at risk EG00172 events41 affected399 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment	EG00079 events41 affected396 at risk EG00174 events36 affected399 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00042 events35 affected396 at risk EG00144 events35 affected399 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00044 events36 affected396 at risk EG00129 events24 affected399 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00022 events20 affected396 at risk EG00112 events10 affected399 at risk
Dizziness	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00062 events51 affected396 at risk EG00156 events45 affected399 at risk
Dysgeusia	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00035 events31 affected396 at risk EG00136 events36 affected399 at risk
Headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00050 events43 affected396 at risk EG00145 events41 affected399 at risk
Insomnia	Psychiatric disorders	MedDRA 26.0	Systematic Assessment	EG00057 events51 affected396 at risk EG00131 events26 affected399 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00091 events74 affected396 at risk EG00163 events60 affected399 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00079 events71 affected396 at risk EG00154 events51 affected399 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00036 events27 affected396 at risk EG00146 events36 affected399 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00026 events24 affected396 at risk EG00127 events27 affected399 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment	EG00025 events22 affected396 at risk EG00128 events26 affected399 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00045 events45 affected396 at risk EG00141 events41 affected399 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00056 events53 affected396 at risk EG00137 events35 affected399 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00085 events69 affected396 at risk EG00147 events34 affected399 at risk
Hypertension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG00044 events34 affected396 at risk EG00141 events38 affected399 at risk
Hypotension	Vascular disorders	MedDRA 26.0	Systematic Assessment	EG00021 events20 affected396 at risk EG00116 events15 affected399 at risk

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D005971	Glutamates
D024342	Amino Acids, Acidic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000600	Amino Acids, Dicarboxylic

ID	Title	Description
BG000	NAC + Neoadjuvant/Adjuvant Pembrolizumab	Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, intravenous (IV); given on cycle day 1] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin [75 mg/m^2, IV; given on cycle day 1] and either Gemcitabine [1000 mg/m^2, IV; given on cycle days 1 and 8] or Pemetrexed [500 mg/m^2, IV; given on cycle day 1]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, IV; given on cycle day 1].
BG001	NAC + Neoadjuvant/Adjuvant Placebo	Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo [normal saline, IV; given on cycle day 1] in combination with platinum doublet NAC, consisting of cisplatin [75 mg/m^2, IV; given on cycle day 1] and either Gemcitabine [1000 mg/m^2, IV; given on cycle days 1 and 8] or Pemetrexed [500 mg/m^2, IV; given on cycle day 1]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo [normal saline, IV; given on cycle day 1].
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pembro + Chemo/Pembro	Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, intravenous (IV); given on cycle day 1] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin [75 mg/m^2, IV; given on cycle day 1] and either Gemcitabine [1000 mg/m^2, IV; given on cycle days 1 and 8] or Pemetrexed [500 mg/m^2, IV; given on cycle day 1]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, IV; given on cycle day 1].	110	397	165	396	389	396
EG001	Placebo + Chemo/Placebo	Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo [normal saline, IV; given on cycle day 1] in combination with platinum doublet NAC, consisting of cisplatin [75 mg/m^2, IV; given on cycle day 1] and either Gemcitabine [1000 mg/m^2, IV; given on cycle days 1 and 8] or Pemetrexed [500 mg/m^2, IV; given on cycle day 1]. Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo [normal saline, IV; given on cycle day 1].	144	400	133	399	388	399

ID	Term
C582435	pembrolizumab
D002945	Cisplatin
D000093542	Gemcitabine
D000068437	Pemetrexed